The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, l-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate.

Individuals with genetic polymorphisms for the genes coding methylenetetrahydrofolate reductase (MTHFR) may not be capable of utilizing or metabolizing folic acid adequately for the vitamin B12 dependent methylation cycle.

Folic acid, including reduced forms1 such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision of a licensed medical practitioner.

V-Natal Tabs is indicated for the distinct nutritional requirements of patients in need of PRENATAL/POSTNATAL dietary supplementation as determined by a licensed medical practitioner. V-Natal Tabs is also indicated as supplementation therapy during pre/post pregnancy as well as while lactating / non-lactating.

V-Natal Tabs should be administered under the supervision of a licensed medical practitioner.

See product ingredients. Consult your licensed healthcare practitioner or pharmacist for more information.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

General

Folate, when administered as a single agent in doses about 0.1 mg daily, may obscure the detection of vitamin B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Folate therapy alone is inadequate for treatment of a vitamin B12 deficiency.

PATIENT INFORMATION

V-Natal Tabs is a PRENATAL / POSTNATAL prescription folate to be used only under licensed medical supervision.

Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin and other anticonvulsants.

Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of capecitabine.

Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folate.

Caution should be exercised with the concomitant use of folinic acid and trimethoprimsulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study.

Folate is a broad term that includes folic acid and all reduced forms including l-methylfolate and folinic acid. V-Natal Tabs does not contain l-methylfolate or folinic acid but these warnings are included as general folate information.

Vitamin B6 should not be given to patients receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6. However, vitamin B6 may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.

Isoniazid can produce a vitamin B6 deficiency.

Drugs which may interact with vitamin D3:

Certain thiazide diuretics, such as hydrochlorothiazide, as well as antacids, bile acid sequestrants (such as cholestyramine), mineral oil, orlistat, olestra, cimetidine, and anticonvulsant medications may reduce the absorption or increase the catabolism of vitamin D.

Vitamin D supplementation should not be given with calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

Drugs which may interact with zinc:

Concomitant administration of zinc supplements and certain antibiotics, specifically tetracyclines and quinolones, may decrease absorption of the antibiotic and potentially reduce its efficacy.

PREGNANCY and NURSING MOTHERS

V-Natal Tabs is intended for use as a prescription PRENATAL folate before, during, and after pregnancy regardless of lactation status.

Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate. Paresthesia, somnolence, nausea and headaches have been reported with vitamin B6. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12.

V-Natal Tabs is supplied as oval, pink film-coated tablets debossed on one side with "VTAB", dispensed in bottles of 90 tablets.

Product Code: 76439-226-90

*This product is a PRENATAL/POSTNATAL prescription folate that contains folate in an amount higher than 0.1 mg, and has an increased risk associated with masking of vitamin B12 deficiency and must be administered under a physician's supervision (AUG 3 1973 FR 20750). This product requires licensed medical supervision and a Rx status as required by pedigree reporting requirements.

Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope.

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